Europe's ATMP Opportunity Still Requires Local Navigation

By Arnaud Deladeriere, Ph.D., Cell&Gene Consulting Inc.

Europe holds many of the ingredients for a strong ATMP ecosystem: clinical expertise, academic manufacturing, translational networks, technology developers, and patient-access infrastructure, yet it feels fragmented to those working inside it and to those outside looking in.

For a developer considering activity there, it's important to first understand the opportunities available, and beyond that, what frictions to expect.

Europe's Accommodating Trial Posture

Importation offers the clearest, most concrete advantage. In one case study discussed during the Foundry gathering, a developer manufacturing outside Europe and running a clinical trial inside one particular country might reasonably expect to duplicate release testing on arrival, covering viability, stability, and potency. Except, that expectation has not been borne out.

Across three to four years of importing a range of products, including autologous and allogeneic CAR-T, iPSC-derived mesenchymal stromal cells, and adenoviral vectors, none required retesting, on grounds principally that insufficient material was available.

First, this reflects experience with one national agency, not a uniform European rule, and the agencies differ. Second, the flexibility is tied to investigational status. For commercial product, the regulation is tightening, and retesting becomes compulsory.

The advantage is therefore precisely where an entrant most needs it, during trials, and it narrows as a program matures toward market. A developer planning a European clinical presence can reasonably build on this flexibility; however, a developer planning European commercialization should not assume it carries forward.

The trial-stage environment reflects a regulatory posture that treats investigational products as investigational. At trial stage, some regulators can take a pragmatic, risk-based view when duplicated testing would consume scarce material without clearly improving patient safety. The harder question is whether commercial frameworks can distinguish more clearly between testing that adds meaningful control and testing that duplicates assurance already generated elsewhere.

That posture is an asset for entrants, and it sits alongside a related reality: batch release in practice is less binary than it can look from the outside, with threshold-based specifications giving qualified persons room to release more batches while accepting variation between them. The clinical reality is often more nuanced than the formal language of compliance suggests.

The Funding Mechanics Undergirding Regulatory Fragmentation

If the regulatory posture is part of the benefits, fragmentation is the friction.

The instinctive explanation is national pride, and there is some of that. The more useful explanation is funding mechanics. Soft funding is often regional and carries regional expectations. A project is meant to advance a particular country, region, or cluster, and meeting those criteria is a condition of accessing the money. Non-collaboration across borders is therefore not always a failure of goodwill but a rational response to how funding is structured, and it becomes ingrained in how developers approach projects.

For an outside developer, appeals to collaborate will not go far if the underlying incentives reward the opposite. To combat fragmentation, we'll need alternative funding structures.

Larger pan-European programs were held up as a counterweight. They create value with the ecosystem they assemble around the money: academics, regulators, patient advocates, companies, technology developers, and specialist service providers.

One reference case was a five-year consortium on TCR-engineered T-cell technology, spanning 29 partners across academia, industry, regulators, and patient advocates. It aimed to optimize the technology and increase access across Europe, and it produced a shared operating context: participants identifying the same challenges and recognizing that these are communal issues.

From that initiative, participants developed a consensus-driven immuno-monitoring panel, led by clinical and industry partners working together, and it exists now as a working standard.

When the funding ended, rather than let the outputs disperse, the participants established a permanent association to house them and continue pursuing harmonization across Europe for the advanced therapy space. The ecosystem outlasted the project that created it, which is what makes it worth an outside developer's attention.

The caveat is implementability. The more elaborate a proposed standard becomes, even one as bounded as an immuno-monitoring panel, the more important it is to ask whether it can run everywhere it is meant to, since a standard that cannot be run everywhere risks hindering the data collection it was meant to enable.

National Strategies Could Organize Europe Or Fragment It Further

National strategies for cell and gene therapy have been rising across Europe, and they are sensible instruments, keeping countries cohesive and building networks of hospitals, centers of excellence, and technology providers capable of supporting proper evidence generation. However, without coordination across those strategies, the region produces well-organized national efforts that do not connect, deepening the fragmentation the strategies were partly meant to address. A patchwork of coherent pieces is still a patchwork.

For a developer entering from outside, this is the practical shape of the problem. Even organizations built specifically to weave networks together are themselves siloed, with market-access expertise sitting apart from regulatory expertise and both apart from tissue engineering, so an entrant should expect to assemble their own map rather than find one.

ATMP Constraints Rest On Underlying Biotech Issues

Much of what gets discussed as a cell and gene therapy problem in Europe is, in fact,  a broader biotech problem, and beyond that a European one.

Europe must take care of its biotech sector in the way it has recently had to care for strategic capability in other sectors. The cell and gene field inherits the consequences of the broader environment rather than generating them alone.

The chain runs longer than the CMC conversation usually allows. It begins with the conditions for translation, moves through company creation, university spinouts, early funding for those companies to get off the ground, and the existence of centers of excellence, arriving only then at where the field's own discussions typically start: a technology that must be paid for and that clinicians must know how to use. Each link conditions the ones after it. A developer evaluating Europe on its clinical expertise or academic manufacturing is looking at the late links while the early ones determine what reaches them.

This is the context in which policy instruments should be read. The European Biotech Act and efforts to foster centers of excellence are aimed at strengthening European biotech competitiveness. The issue is being addressed at that level, but top-down measures are not enough on their own. They need a bottom-up shift in how organizations operate.

For an outside developer, the practical consequence is knowing what to attribute to what. Frictions encountered in Europe are frequently not ATMP-specific and will not be resolved by ATMP-specific means or by finding a better-organized cell therapy partner. They are conditions of the wider biotech environment, being addressed slowly and at the policy level, and they should be priced into timelines rather than treated as obstacles a sufficiently good local partner can route around.

In Vivo Is The Unresolved Test Case

The question is whether Europe is about to repeat with in vivo CAR-T what it experienced with autologous ex vivo CAR-T, with each group privately developing its own recipes, with fragmentation hampering patient access after the fac.

The economics should be more favorable. Access problems divide into two questions:

The first is a business question related to cost and reimbursement. The second is a technical one on the need for validated centers because not every center can administer these therapies.

In vivo eases the first: a centrally produced, off-the-shelf, single-injection product resembles the traditional pharmaceutical model more closely than autologous CAR-T does, produced centrally, stored, and given once.

The second constraint, however, does not disappear under the in vivo model (and may even sharpen) Clinical teams still need to anticipate and manage the consequences of in vivo engineering, and experienced validated centers remain necessary.

That asymmetry creates an argument for  building evidence generation and analytical harmonization frameworks before the therapies arrive rather than retrofitted afterward. For a developer weighing when to engage with Europe on an in vivo program, this is a window: the standards are not yet fixed, and there is room to shape them by participating early rather than inheriting them late.

Regulatory alignment means regulators reasoning from similar thinking and calibrating risk on similar criteria, which then must be translated into guidelines and practice. Alignment is the most achievable goal: it is driven substantially by commercial incentives rather than goodwill, and closed forums that convene regulators from multiple regions to reason together are among the instruments that can produce it.

Closing Perspective

Europe offers a dense set of capabilities, incentives, institutions, and national systems that have not yet been fully organized into a coherent route for ATMP developers.

For global developers, the practical lesson is to identify the centers of excellence relevant to the specific problem, understand which frictions are ATMP-specific and which are broader biotech constraints, and engage early where standards are still forming.

Key Takeaways

About The Author:

Arnaud Deladeriere, Ph.D., is principal consultant at Cell&Gene Consulting Inc. Previously, he was head of MSAT and Manufacturing at Triumvira Immunologics, and before that, manufacturing manager at C3i. He received his Ph.D. in biochemistry from the University of Cambridge.